The Benefits of Pharmacogenetic Testing

Ruben Bonilla-Guerrero

Erin Lopata

Pharmacogenetics presents clinicians an attractive option to optimize drug therapy, minimize harmful effects, and contain costs; but, payers may not be taking full advantage of cost-saving potential by choosing only to cover the costs associated with interrogating a single gene.

Reports vary, but the cost of testing a single gene appears to range from $100 to $500, depending on the source. The cost of running an entire panel is a similar price. 

Despite the virtually negative cost differential, payers are reluctant to cover the cost of running a full panel of tests. This common practice raises the question of why many payer organizations do not pay for running an entire test panel. Experts differ in their speculations as to why this is the case.

“I don’t think they’re familiar with the total body of knowledge,” says Ruben Bonilla-Guerrero, MD, FACMG, FAACC, MB(ASCP), CGMBS, medical director of medical affairs at Admera Health, a leader in personalized medicine and non-invasive cancer testing in South Plainfield, New Jersey. “Insurance companies consider running a pharmacogenetic test panel as experimental even though the labels on more than 200 drugs mention pharmacogenetics testing.”

Related: Genetic Testing in Treatment Decision Making Goes Mainstream

Pharmacogenetic testing offers important advantages by facilitating the prescriber’s ability to select, initiate, and adjust a pharmaceutical drug product with a much higher level of precision than previously available with conventional dose titration. Pre-emptive testing also helps prevent adverse drug events that occur as a result of overdosing medications.

However, like many areas of healthcare, weighing the cost against the purported benefits is also critical.

“Payers want to reimburse for tests that are done for a specific indication and that have evidence-based, actionable treatments based on the results,” says Erin Lopata, PharmD, MPH, senior director of the Access Experience Team at Precision for Value, part of Precision Value & Health, which performs value and access consulting services for entities that may be involved in value-based contracting.

Some provider habits may inadvertently contribute to payer pushback. In some cases, providers may order tests on certain populations, medications, genes, and gene–drug pairs or add their own tests. Sometimes, they base their decisions to order these tests on misleading information purported by the mainstream media that is devoid of clinical application or value to the patient. In such cases, ordering extra tests would be impractical.

Here, Bonilla-Guerrero says it would be impractical to have payers cover these tests. He believes providing education to payers about the circumstances under which interrogating a gene panel would prove most beneficial for the patient. He encourages organizations to have conversations with payers and other stakeholders involved determining coverage for pharmacogenetic testing.

“It’s about having a conversation about what’s actionable, the available sources, and the clinical utility,” says Bonilla-Guerrero.

Lopata points out that organizations should exercise prudence when ordering panels, as failure to do so could promote negative stigmas associated with testing while giving rise to ineffective medication use.

For example, “fishing expeditions” occur when prescribers run large panels to diagnose or identify a treatment for a condition. Engaging in such practices can promote off-label prescribing for specific mutations in cases where sufficient evidence is lacking. Off-label medication use tends to be relatively common in the oncology world-a therapeutic area in which Lopata says research evolves quickly and exhausting treatment options is common.

However, having sufficient evidence does not always guarantee therapeutic success.  The evidence derived from pharmacogenetic testing may translate to poorer outcomes when presented to some patients. A study published in Pharmacogenomics Journal in 2013 found that pharmacogenetic testing can create patient doubt or distrust when the results indicated that a drug preferred or trusted by a patient is less effective or safe for the patient. The anxiety and distrust that may follow can negatively affect patient perceptions and adherence-a direct consequence of being prescribed a therapy the patient perceives as less effective or inferior.

Looking forward, Lopata anticipates payers will shift their focus on containing costs in oncology. She believes evidence will continue to play an essential role across all therapeutic areas. 

“Evidence generation to determine the best timing and test to use (panel vs. single-mutation) will support better payer coverage and patient access to these tests,” she says.

Frieda Wiley, PharmD, RPh, is a contract writer and consultant pharmacist.